Recently, we pointed to sunscreen as a test case — one that could help reveal whether the FDA’s stated intention of reducing animal research and embracing ethical science is genuine (as opposed to popular-but-largely-empty rhetoric).
Now, we might have an answer. And, it’s not good.
On July 19, Citeline reported that — “despite the agency’s commitment to non-animal methods” — the FDA’s position remains that “animal tests are the only viable option right now for assessing the systemic effects of sunscreens.”
Indeed, the FDA’s acting director of the Center for Drug Evaluation and Research had just told a House Committee that the agency currently has “no non-animal tests . . . that answer these safety questions for sunscreen UV filters….” and that the agency is “using animal studies” to test “multi-organ system toxicities”.
According to the FDA, then, the United States — a country that touts itself as the global leader in science and innovation — has no viable non-animal tests for sunscreen. And, somehow, it’s the only one.
In the face of this glaring and inexplicable contradiction, the FDA tried to hide behind a familiar excuse: that the U.S. treats sunscreen as a drug, unlike other countries that regulate it as a cosmetic.
But that cover didn’t hold.
Congressman and medical doctor John Joyce (R-PA) — both a dermatologist and a melanoma survivor — called the situation just what it is: a clear “‘failure of the FDA’”. He put on the record that other countries, even those that also regulate sunscreens as drugs, have found ways to ensure high safety standards without blocking public access to more innovative and effective products (as well as more modern and ethical science).
Representative Troy Balderson (R-OH) added further pressure, questioning the FDA’s “‘slow’ implementation of real-world evidence (RWE) in its regulatory processes and reminding the agency that“‘Congress has made clear its intent for the FDA to incorporate [RWE] during its review and approval processes’ for sunscreen filters”.
This telling exchange only reinforces what we’ve previously laid plain: the FDA’s entrenched position ignores decades of real-world human use data and defies international scientific consensus.
In short, the FDA’s sunscreen decisions are based neither on science nor on a demonstrable interest in protecting public health.
(As we’ve lamented, the FDA intends to require new animal testing for sunscreen ingredients that have already been used by humans for nearly 50 years without any significant or notable safety issues.)
It also underscores the importance of newly-introduced federal legislation: the Supporting Accessible, Flexible and Effective (SAFE) Sunscreen Standards Act (H.R. 3686).
Introduced in June 2025 by the co-chairs of the Congressional Skin Cancer Caucus — including Representative Joyce — this bill seeks to address directly the FDA’s sunscreen-specific regulatory failure (i.e., its white-knuckling of animal research) by:
- Requiring the FDA to develop clearer, more flexible standards for evaluating sunscreen ingredients;
- Mandating that the FDA consider non-animal tests like in vitro assays, organs-on-chip models, and computational tools;
- Requiring guidance (within 180 days of enactment) on how non-animal methods could be used to meet safety and efficacy standards;
- Allowing the use of real-world evidence, observational data, and nontraditional scientific inputs; and
- Empowering the agency to move toward modern, ethical, and human-relevant science (i.e., to do just what the FDA claims it wants to do).
The Skin Cancer Foundation has called the bill “a significant step in providing more options for sun protection and skin cancer prevention that will ultimately save lives” – we agree and recognize that, critically, this bill would save lives across species.
Sunscreen is a clear example of how animal research harms everyone, humans included. And it exposes how deeply the animal research industry is embedded in U.S. regulatory systems — as well as how its grip continues to block scientific progress and public health improvements.
That’s why H.R. 3686 is so urgent.
This isn’t *just* about sunscreen. It’s about a political system so rigged in favor of entrenched corporate interests that animal testing continues even in the face of inter-industry dissension. (In fact, many industry players, including trade associations and cosmetic product and ingredient manufactures, are promoting the use of non-animal testing methods for sunscreen.)
So, what does this tell us?
It tells us that the animal industrial complex is still controlling.
It tells us that science alone won’t drive change — only public pressure will.
And, it tells us that we must ramp up the pressure right now.
Your call to action: Urge your representative to support H.R. 3686 as a necessary, commonsense step toward improving public health, protecting animals, and ensuring that regulatory decisions become based on real-world evidence — not industry inertia.
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